Ion Robotic Bronchoscopy System

The Ion Endoluminal System enables robotic-assisted bronchoscopy for diagnosing peripheral pulmonary lesions, utilizing shape-sensing technology to navigate the complex bronchial tree with precision previously unattainable through conventional bronchoscopy.

Product Overview

Registered in China as “Ion支气管导航操作控制系统” under registration number 国械注进20243010155, the system received NMPA approval in March 2024 and achieved first commercial installation in September 2024. It represents Intuitive Fosun’s second major product line following the da Vinci surgical platform.

The Ion system addresses a critical clinical need in China, where lung cancer ranks as the most commonly diagnosed cancer and leading cause of cancer mortality. Early-stage detection of peripheral lung nodules—often located beyond the reach of conventional bronchoscopes—can significantly improve treatment outcomes and survival rates.

Key Features

For peripheral lung lesion biopsy in China, Intuitive Fosun’s Ion system uses a 3.5 mm shape-sensing catheter with 180° articulation to access all 18 lung segments with a stability lock during tissue sampling.

• Shape-Sensing Technology: Fiber optic sensors embedded in the catheter provide real-time shape data, enabling precise navigation without fluoroscopy
• Ultra-Thin Catheter: 3.5mm outer diameter catheter accesses peripheral airways to reach all 18 lung segments
• Articulating Tip: 180-degree articulation enables navigation around sharp bronchial angles
• Integrated Vision: Direct visualization combined with navigation data for confident lesion targeting
• Stability Lock: Catheter position locks in place during biopsy to minimize target displacement
• Peripheral Reach: Designed specifically for lesions beyond the reach of conventional and standard robotic bronchoscopes

Technical Specifications

For peripheral lung lesion biopsy, Ion’s 3.5 mm catheter articulates 180° with fiber optic shape sensing to reach all 18 lung segments, supporting standard biopsy needle and forceps tools.

System Components

Controller: Houses the shape-sensing processing unit and provides the surgeon interface for catheter manipulation and navigation visualization.

Catheter: Single-use articulating catheter with embedded fiber optic shape sensors, available in multiple configurations for different anatomical approaches.

Planning Software: CT-based procedure planning with 3D airway reconstruction and lesion targeting for pre-procedure preparation.

Biopsy Instruments: Compatible with standard bronchoscopic biopsy tools including needles, forceps, and brushes. Certain biopsy needles are manufactured locally at Intuitive Fosun’s Shanghai facility.

Clinical Applications

Primary Indication: Diagnosis of peripheral pulmonary nodules and masses suspicious for malignancy

Procedure Workflow:

1. Pre-procedure CT scan for airway mapping and lesion localization
2. Planning software creates navigation pathway
3. Shape-sensing catheter navigated to target under real-time guidance
4. Position confirmed and locked
5. Biopsy instruments deployed through working channel
6. Tissue samples obtained for pathological analysis

The system enables tissue diagnosis of lesions that would otherwise require more invasive surgical biopsy or CT-guided percutaneous approaches, potentially reducing complications and patient recovery time.

Regulatory Status

Note: The China registration number indicates import classification (进), as the complete system is imported while certain consumables are manufactured locally.

Market Context

The Ion system enters China as the second robotic bronchoscopy platform following Johnson & Johnson’s Monarch system. Both systems target the growing need for minimally invasive lung cancer diagnosis driven by:

• Increasing CT screening programs detecting incidental pulmonary nodules
• Lung cancer’s position as China’s most common cancer
• Clinical preference for tissue diagnosis before treatment planning
• Limitations of conventional bronchoscopy for peripheral lesions

Intuitive Fosun reported 4 Ion installations in China during 2024, with expectations for accelerated adoption as clinical experience accumulates and training programs expand.

Manufacturing & Localization

While the Ion system itself carries import registration, Intuitive Fosun manufactures a significant portion of consumables locally at its Shanghai facility. The company reports that locally produced biopsy needles for the Ion system supply 70% of global demand, representing a “Made in China for Global Supply” achievement.

This partial localization supports cost management for procedure consumables while maintaining the complete system’s import status for regulatory purposes.

Training Requirements

Ion system operation requires specific credentialing beyond general bronchoscopy training. Intuitive Fosun’s training program includes:

• Didactic education on shape-sensing technology and system operation
• Simulation training on procedure planning and navigation
• Proctored initial cases with experienced clinical support
• Ongoing case support from dedicated field clinical engineers

Frequently Asked Questions

What types of lung lesions can Ion diagnose?

Ion is designed for peripheral pulmonary lesions—nodules and masses located in the outer two-thirds of the lung where conventional bronchoscopes cannot reach. Lesions as small as 10-30mm can be accessed, though diagnostic yield varies with lesion size, location, and characteristics.

How does Ion compare to CT-guided percutaneous biopsy?

Ion approaches lesions through natural airways rather than through the chest wall, potentially reducing pneumothorax risk compared to percutaneous approaches. However, diagnostic yield may vary, and patient selection depends on lesion location, size, and patient factors. Clinical teams typically evaluate both approaches for individual cases.

Is Ion suitable for treatment or only diagnosis?

The primary approved indication is diagnostic biopsy. However, the platform’s navigation capabilities are being explored for therapeutic applications including tumor marking and ablation catheter placement in research settings.